Dynamic Monitoring of ctDNA and HPV DNA in Plasma for the Early Prediction of Recurrence After Cervical Cancer Surgery

The Third Affiliated Hospital of Guangzhou Medical University

Status: Enrolling

Conditions: cfHPV DNA in Plasma of Cervical Cancer Patients

Treatments: Diagnostic Test: Assess the risk of recurrence and the efficacy of medication

Study type: Observational

Funder types: Other

Identifiers

NCT06420427

CCA2024005

Details and patient eligibility

About

Assess the sensitivity, specificity, positive predictive value, and negative predictive value of dynamic monitoring of circulating tumor DNA (ctDNA) combined with circulating HPV DNA (cfHPV DNA) for early prediction of recurrence in cervical cancer post-surgery or post-treatment, and compare its advantages and disadvantages with existing diagnostic methods.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with newly diagnosed HPV-positive cervical malignancy at stages I-IV who have not undergone surgery, radiation therapy, or chemotherapy.
• Patients must be older than 18 years of age.
• Cervical cancer patients who are eligible for surgery and/or chemoradiotherapy.
• Estimated life expectancy of more than three months.
• Understands the study protocol and voluntarily participates in the research by signing the informed consent form.
• Able to provide specimens and corresponding clinical information at each time point.

Exclusion criteria

• Patients who are participating in other clinical trials.
• Pregnant or breastfeeding women.
• Patients with severe mental illness.
• Patients who voluntarily withdraw.
• Patients unable to complete the study protocol.